| Dalteparin Sodium | ||||
| Source | Intestinal mucosa of pigs | |||
| Quality standard |
USP |
EP |
||
|
characters |
Appearance |
/ |
white or almost white; hygroscopic powder | |
| solubility |
/ |
freely soluble in water | ||
| identification | The ppm values for the methyl group of N-acetyl, the H-2 of N-sulfo glucosamine, the H-2 of glucuronic acid plus 3-O-sulfo glucosamine, the H-1 of iduronic acid and the H-1 of the 2-O-sulfo iduronic acid linked to the terminal anhydromannitol, the H-1 of 2-O-sulfo iduronic acid and the H-1 of 3-O- sulfo glucosamine of dalteparin in the Sample solution are present at 2.05, 3.28, 3.39, 5.01, 5.18-5.22, and 5.51, respectively. The ppm values of these signals do not differ by more than±0.03ppm | The 13C NMR spectrum obtained is similar to that obtained with the appropriate specific dalteparin sodium CRS | ||
| Mw : 5600 -6400Da, M≤3000 : NMT 13.0%,M≥8000:15.0%-25.0% | Mw : 5600 -6400Da, M≤3000 : NMT 13.0%,M≥8000:15.0%-25.0% | |||
| Anti- Xa activity/ anti- IIa : 1.9-3.2 | Anti- Xa activity/ anti- IIa : 1.9-3.2 | |||
| Meets the requirements for Sodium Content | It complies with the test for sodium | |||
| Appearance of solution | / | clear；NMT: intensity 5 | ||
| pH | 5.5-8.0 | 5.5-8.0 | ||
| Molar ratio of Sulfate carboxylate | ≥1.8 | ≥ 1.8 | ||
| Nitrogen | 1.5 %-2.5 % (on the dried basis) | 1.5 %-2.5 % (on the dried basis) | ||
| Sodium | 10.5% -13.5% (on the dried basis) | 10.5% -13.5% (on the dried basis) | ||
| Nitrite | ≤ 5ppm | ≤ 5ppm | ||
| Loss on drying | ≤10.0% | ≤5.0% | ||
| Bacterial endotoxins | ＜0.01EU/U | ＜0.01EU/IU | ||
| Boron | ≤1ppm | ≤ 1ppm | ||
| Assay | Anti- Xa activity | 110-210 IU/mg (on the dried basis) | 110-210 IU/mg (on the dried basis) | |
| Anti- IIa activity | 35-100 IU/mg (on the dried basis) | 35-100 IU/mg (on the dried basis) | ||